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LUMBAR STENOSISNCT07883694

Pain After Microsurgical Decompression

An observational study of LUMBAR STENOSIS, run by Aalborg University at 1 site in Denmark.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This prospective observational cohort study aims to determine whether a combination of preoperative clinical, psychological, sleep-related, inflammatory, genetic, and epigenetic factors can predict chronic postoperative pain 12 months after microsurgical decompression surgery in patients with lumbar spinal stenosis. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
LUMBAR STENOSIS
How many people
200 participants
Where
1 siteDenmark
Study dates
1 Nov 2026to 31 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

Study population: Adults aged 18-80 years with symptomatic lumbar spinal stenosis and radiating leg pain who are scheduled to undergo microsurgical decompression surgery. Participants will be recruited preoperatively and followed for 12 months after surgery to evaluate chronic postoperative pain outcomes.

Who may be able to join

  • Age 18-80 years
  • Radiating leg pain
  • Scheduled for microsurgical decompression surgery
  • Able to provide informed consent

Who cannot join

  • Pregnancy
  • Drug addiction (cannabis, opioids, or other drugs)
  • Alcohol addiction
  • Unable to comply with study procedures
  • No access to smartphone, tablet, or computer

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Denmark1 site

  • Budolfi Privathospital

    Aalborg, 9200

Other trials in Denmark

About this study

Official title: Prediction and Assessment of Chronic Postoperative Pain Following Microsurgical Decompression

This prospective observational cohort study aims to determine whether a combination of preoperative clinical, psychological, sleep-related, inflammatory, genetic, and epigenetic factors can predict chronic postoperative pain 12 months after microsurgical decompression surgery in patients with lumbar spinal stenosis. Participants will undergo preoperative blood sampling and questionnaire assessment before surgery and complete follow-up questionnaires 12 months after surgery.

Read the detailed description

Lumbar spinal stenosis is a common cause of pain and disability, and although microsurgical decompression surgery is effective for many patients, some continue to experience chronic postoperative pain. Previous studies have identified risk factors related to pain mechanisms, psychological characteristics, inflammation, and molecular biomarkers, but currently no predictive model has sufficient accuracy for clinical use. This study investigates whether combining multiple preoperative assessments can improve prediction of chronic postoperative pain 12 months after surgery. Variables include pain-related questionnaires, sleep quality, inflammatory biomarkers, circulating microRNAs, telomere length, and circulating nucleosome epigenomic profiling. Machine learning methods will be employed to develop predictive models.

Conditions
LUMBAR STENOSIS
Keywords
Lumbar Stenosis, Microsurgical decompression, Pain, Postoperative pain, Longitudinal
Medical subject headings
Constriction, Pathologic, Pain, Pain, Postoperative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chronic postoperative pain at 12 months

    Chronic postoperative pain will be assessed 12 months after microsurgical decompression surgery using an 11-point Numeric Rating Scale (NRS). Participants will rate their average pain intensity during the previous week on a scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Higher scores indicate greater pain intensity and a less favorable outcome.

    Measured: From enrollment to the 12-month follow-up

  2. Roland-Morris Disability Questionnaire (RMDQ) Score

    Back pain-related disability assessed using the Roland-Morris Disability Questionnaire. Total scores range from 0 to 24, with higher scores indicating greater disability and functional impairment.

    Measured: From enrollment to the 12-month follow-up

Secondary outcomes (11)

  1. PainDETECT Questionnaire Score

    Chronic postoperative pain will be assessed 12 months after microsurgical decompression surgery using an 11-point Numeric Rating Scale (NRS). Participants will rate their average pain intensity during the previous week on a scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Higher scores indicate greater pain intensity and a less favorable outcome. This outcome will be used to evaluate persistent pain following surgery and as the primary endpoint for development and evaluation of prognostic prediction models.

    Measured: From enrollment to the 12-month follow-up

  2. Pain Catastrophizing Scale

    Pain-related catastrophic thinking assessed using the Pain Catastrophizing Scale. Total scores range from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.

    Measured: From enrollment to the 12-month follow-up

  3. Hospital Anxiety and Depression Scale (HADS) Anxiety Score

    Symptoms of anxiety assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.

    Measured: From enrollment to the 12-month follow-up

  4. Hospital Anxiety and Depression Scale (HADS) Depression Score

    Symptoms of depression assessed using the depression subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe depressive symptoms.

    Measured: From enrollment to the 12-month follow-up

  5. Pittsburgh Sleep Quality Index (PSQI) Score

    Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.

    Measured: From enrollment to the 12-month follow-up

  6. C-Reactive Protein (CRP)

    Systemic inflammation assessed by measurement of plasma C-reactive protein concentration obtained from venous blood samples. Values are reported in mg/L, with higher values indicating greater systemic inflammatory activity.

    Measured: Immediately before surgery

  7. Inflammatory Protein Profile

    Inflammatory biomarker concentrations assessed using the Olink® Target 96 Inflammation panel. Protein expression levels are reported as Normalized Protein eXpression (NPX) values on a log2 scale, with higher NPX values indicating higher relative protein abundance.

    Measured: Immediately before surgery

  8. Circulating microRNA Expression Profile

    Circulating microRNA expression assessed from plasma samples using next-generation sequencing. Expression levels will be reported as normalized sequencing counts and used as exploratory prognostic biomarkers.

    Measured: Immediately before surgery

  9. Telomere Length

    Biological aging assessed by measurement of absolute telomere length from blood-derived DNA using quantitative polymerase chain reaction (qPCR). Telomere length will be reported as laboratory-specific quantitative measures, with shorter telomeres generally indicating greater biological aging.

    Measured: Immediately before surgery

  10. Circulating Nucleosome Epigenomic Profile

    Genome-wide epigenetic signatures assessed from circulating nucleosomes isolated from plasma samples. Analyses include DNA methylation patterns and histone post-translational modifications, reported as normalized assay-specific measures and evaluated as exploratory prognostic biomarkers.

    Measured: Immediately before surgery

  11. Pain Medication Use

    Self-reported use of analgesic medications assessed through questionnaire data. Medication use will be categorized according to type and frequency of use, with higher use reflecting a greater need for pain management.

    Measured: Immediately before surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07883694
Sponsor's protocol ID
AAAU20260043
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of LUMBAR STENOSIS, run by Aalborg University at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic postoperative pain at 12 months (time frame: From enrollment to the 12-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07883694.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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